FDA 510(k), K163714, OSSIX BONE

FDA 510(k), K163714, OSSIX BONE

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510(K) Number: K163714
Device Name: OSSIX BONE
Manufacturer: Arie Goldlust
Device Classification Name: Bone Grafting Material, Animal Source
Regulation Number: NPM
Classification Product Code: KXA
Date Received: 12/30/2016
Decision Date: 07/18/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
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